Handgun related violence epidemic will begin today in Washington DC
A split Supreme Court today declared that the Second Amendment protects an individual’s right to own guns for self-defense, striking down the District of Columbia’s ban on handgun ownership as unconstitutional. Be prepared for an increase in gun violence in DC.
District of Columbia officials argued they had the responsibility to impose “reasonable” weapons restrictions to reduce violent crime. Intrestingly Justice Breyer argued in his dissent that the framers of the Constitution did not present self-defense as their main reason for the Second Amendment. “The self-defense interest in maintaining loaded handguns in the home to shoot intruders is not the primary interest, but at most a subsidiary interest,” he wrote. “The Second Amendment’s language, while speaking of a ‘militia,’ says nothing of ‘self-defense.’ ”
SOURCE: The Washington Post – September 18, 2007
Only since 1986 was Emergency room physicians mandated to provide care to all patients – regardless of their medical condition, age, or ability to pay. Before 1986, some hospitals participated in a practice called “patient dumping” as a solution to address emergency department overcrowding. Patient dumping is the denial of care by hospital emergency departments despite being capable of providing the needed medical care. Patient dumping is defined as the transfer of patients from one hospital to another based on the patient’s inability to pay for care. Schiff (1986) reported that 250,000 inappropriate transfers of medically unstable patients occurred, resulting in increased patient morbidity and mortality. The reason this is import behavior to critique, is that it was the founding action of a federal law that eventually became a contributor to the emergency department overcrowding situation.
Congress created and passed the Emergency Medical Treatment and Active Labor Act (“EMTALA”) as a response to “patient dumping”, EMTALA was written so that federally funded hospitals were required to give emergency aid in order to “stabilize” a patient suffering from an “emergency medical condition” or “active labor” before discharging or transferring that patient to another facility (Fosmire, 2003). An “emergency medical condition” is defined by Section (e)(1) of EMTALA as a condition with “acute symptoms” of a “sufficient severity” such that the absence of “immediate medical attention” could reasonably be expected to result in serious health risks and/or disability. The courts have interpreted the phrase “emergency medical condition” to mean a condition which puts the patient in imminent danger of death or serious disability. Unfortunally hospitals still do practice patient dumping.
In order to combat “patient dumping” hospital must fulfill six duties. They include providing a medical screening examination to all patients that present themselves ED premises regardless of ability to pay; providing stabilizing care; not transferring patients who are potentially unstable if the hospital has the capabilities to treat the patient (Patients may only be transferred under EMTALA for medical necessity such as burn patients who need a Burn Unit); providing medically appropriate transfers where the patient is transferred for medically necessity; maintaining an on-call system for physicians to provide coverage to be available to assist stabilizing patients; and accepting requests for in-coming transfer if the hospital has the specialized capabilities needed by the patient, and the transferring hospital is relatively less able to care for the patient (Fosmire, 2003).
Federal government penalties under EMTALA may be against hospitals and or individual physicians if they negligently dump a patient. They may face civil penalties up to $50,000/violation and or exclusion from participation in the Medicare and Medicaid reimbursement programs. In addition, EMTALA allows for civil actions for individual who experience personal harm. Interestingly, enforcement of EMTALA remains a patient complaint-driven process. In other words, the investigation of a hospital’s practices, are initiated only by a patient or public complaint. Thus, there is no federal “EMTALA Police” performing undercover hospital inspections. However, as patients become more consumer-oriented and informed about their patient rights, it is probable that dissenting hospitals and physicians will be identified and curtailed.
For the next 4 to 5 weeks, I am going to put together an educational primer for people interested in the Movie SiCKO, a political documentary film about pharmaceutical companies and of Food and Drug Administration by Michael Moore, scheduled for release in the United States on June 29, 2007. What is interesting is that Mr. Moore isn’t bringing up anything new….pharmaceutical and health insurance companies have been behaving like this for years. In any case, by reading this blog the next few weeks, I hope that you will educate yourself about several concepts before seeing the movie.
The concept: “Prescriber Profiling”
The players: Pharmaceutical Companies, American Medical Association (AMA), data mining companies.
How it works:The American Medical Association license access to it’s AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors to data-mining companies. The data mining companies, known as health information organizations (HIOs), then links this individual physician data to their demographic data and their prescription record. They then sell this linked database to sell them to pharmaceutical companies.
The pharmaceutical industry then employs approximately one sales representative for every 5 office-based physicians. A representative can quickly access a breakdown of pharmaceuticals prescribed by any physician on a handheld computer, enabling that representative to deliver a tailored marketing pitch to physicians selected for their current prescribing habits. Within weeks, the sales representative can monitor each physician’s response to the pitch—as well as to inducements, such as meals, gifts, and drug samples—and can make repeated visits to achieve sales goals. They can also identify physicians who prescribe a competitors’ drug and target them with campaigns touting their own products. Salespeople chart the changes in a doctor’s prescribing patterns to see whether their visits and offers of free meals and gifts are having the desired effect.
Critics claim that Prescriber Profiling biases the doctor-patient relationship, and it’s driving up costs. The pharmaceutical industry defends the practice as a way of better educating physicians about NEW drugs. Critics reply that this type of drug marketing serves mainly to influence physicians to prescribe more expensive NEW medicines, not necessarily to provide the best treatment.
After complaints from some members, the AMA last year began allowing doctors to “opt out” and shield their individual prescribing information from salespeople, although drug companies can still get it. So far, 7,476 doctors have opted out, AMA officials said. Some critics, however, contend that the AMA’s opt-out is not well publicized or tough enough, noting that doctors must renew it every three years. Furthermore critics claim that the AMA is reluctant to change it’s behavior because of it’s $44.5 million in revenue from the sale of database products (in 2005)—16% of the AMA’s total revenue for that year. They stress that patient names are encrypted early in the process and cannot be accessed, even by the data-mining companies.
Doctors, Legislators Resist Drugmakers’ Prying Eyes By Christopher Lee. Washington Post, Tuesday, May 22, 2007; Page A01.
Prescriber Profiling: Time to Call It Quits. David Grande. Annals of Internal Medicine. 15 May 2007. Volume 146 Issue 10. Pages 751-752.
For the next 4 to 5 weeks, I am going to put together an educational primer for people interested in the Movie SiCKO, a political documentary film by Michael Moore, scheduled for release in the
United States on June 29, 2007. It will investigate health care with a focus on large American pharmaceutical companies and the Food and Drug Administration. I haven’t seen the movie yet however I intend to. What’s interesting is that Mr. Moore isn’t bring up anything new….pharmaceutical and health insurance companies have been behaving badlyfor years. In any case, by reading this blog the next few weeks, I hope that you will educate yourself about several concepts before seeing the movie.
The concept: “Me-too drugs”
The players: Pharmaceutical Companies
The Scoop: The pharmaceutical industry is not especially innovative or inventive. The great majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,
“If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?”
Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, of which seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market. Only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). Of the 7 drugs discussed above, not one came from a major US drug company.
Case in Point: Nexium, a “me-too” drug for stomach acid, has earned approximately $5 billion for its maker, AstraZeneca, since it went on the market in 2001. Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
Is Nexium better? So far, there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.
The problem with Me-Too drugs is that they are always marketed as BETTER than what’s already available. However, the FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs,” Stafford says. “I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market. So consumers feel compelled to leave their current regime–even if it’s working–for these drugs. Me-Too drugs also COST SUBSTANTIALLY more–forget about lowering prices.
1. The Truth About the Drug Companies ByMarcia Angell
2. “Me-too drugs, Sometimes they’re just the same old, same old” By Rosanne Spector.